While You Were Throwing Snowballs

At least on the East Coast, March has apparently lived up to its reputation and come in like a large cat. Here at IVB we're not so much concerned with the way it begins and ends, but instead would rather focus on the Madness in between.

Speaking of madness: while you were making snowmen ...

• That Sebelius/HHS announcement that made so much news this weekend? Ramsey Baghdadi had the scoop for the IN VIVO Blog.
  
• Art imitates life imitating comedy imitating sad state of the world: Pharma Giles at PharmaGossip.
  
• Wyeth's Prevenar approved in Russia.
• Roche scheme to enhance Pulmozyme compliance probably needed a little more thought, don'cha think? The company has now been censured in the UK for giving out Toys R Us gift certificates to children on the drug, reports the FT.
  
• Actelion's application to expand Tracleer's use into PAH patients with less severe disease greeted with a complete response letter from FDA. FDA says Actelion's REMS first needs to be finalized and approved before it can finish its review of the sNDA.
• Have higher regulatory hurdles affected investment in early-stage Type-2 diabetes companies? VCs weigh in at The Pink Sheet.
  
• Offenses across the NFC East are breathing easier. Sadly, Brian Dawkins, no longer an Eagle, signs 5-year deal with Denver Broncos.
  

The IN VIVO Blog Podcast: Comparative Effectiveness, HHS Candidates, and Health Reform

Welcome to the first IN VIVO Blog podcast. We know ... it took us a while, but we finally got there. There will be many different kinds of podcasts from various reporters and editors of the IN VIVO Blog, which includes writers of The RPM Report, IN VIVO, The Pink Sheet, Start-Up and other publications.

Our first podcast comes to you from the editors of The RPM Report. It's called "3 things in 3 minutes." What is it? It's just that: 3 topics that we try and discuss in 3 minutes (we went a little over).

The topics for this discussion? Comparative effectiveness, the next HHS Secretary, and whether Medicare Part D should be a model for health care reform. If you listen closely, you may even be rewarded with a "bonus topic."

Click here to listen to the podcast.

So tell us what you think. We'd love to hear your thoughts. Just be gentle.

FDA Commissioner Update

It looks as if the Race to White Oak is almost over. We know at least one commissioner candidate was informed of the decision yesterday.

As we said previously, a decision was likely to be made yesterday with an announcement coming later this week or soon thereafter. To read our previous post, click here.

We also understand that David Dorsey could be named FDA Chief Counsel and Bill Schultz could be named HHS General Counsel. Both picks would make a lot of sense.

Dorsey previously worked in the FDA Office of the Chief Counsel before leaving temporarily to join the staff of Senate Health, Education, Labor and Pensions Committee Chairman Ted Kennedy. Dorsey returned to the agency last week.

Schultz, if named HHS General Counsel, would be the second former staffer of House Energy & Commerce Chairman Henry Waxman to ascend to a top position in the health department. Schultz previously served as counsel to Waxman on food and health care issues.

He was also deputy commissioner for policy at FDA and a former assistant deputy attorney general. Schultz most recently involved in negotiations over an abbreviated approval pathway for follow-on biologics. As a partner with Zuckerman Spaeder, he was one of four principal negotiators of compromise legislation and represented the generic drug industry in those talks. To read our coverage of FOBs, click here.

Dorsey was also heavily involved in the FOBs negotiations on the Senate side as a staffer to Kennedy.

We'll let you know when we find out more.

BioShield Giveth, BioShield Taketh Away

Yesterday the Dept. of Health and Human Services notified Vaxgen that since the biotech was in default of its $877 million contract to provide the government with 75 million doses of anthrax vaccine for missing a milestone, HHS was canceling the order. The New York Times has the story here.

The grant--the largest chunk of the government's $5.6 billion Project Bioshield program--wasn't payable until Vaxgen started delivering vaccine. As such, the company is pretty much out of luck, although it can appeal HHS' decision. Making matters worse for the California biotech, HHS reserves the right to hold the company financially liable for costs associated with finding a replacement, noting that "Vaxgen's failure to perform is not excusable," according to a HHS letter sent to the company. Happy Holidays!

BioShield hasn't turned out as hoped. Most of the cash is earmarked for products only once they've neared or received approval, but deep-pocketed firms have been reluctant to assume the R&D risk for at-best uncertain financial gain. And the Vaxgen debacle illustrates some of the problems that those willing but much smaller firms with few resources can run into.

Congress may attempt to remedy the situation by throwing more money at it--as announced in mid-November. The proposed additional $1 billion could support research and early development at biotech companies. Critics suggest the boost is unlikely to fix BioShield, and regardless, whether HHS has any luck playing VC remains to be seen.